Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMercy Medical Center
About this trial
Investigators want to compare the seroconversion rates between two-dose and three-dose regimens of the hepatitis B vaccine (Heplisav B) among patients with cirrhosis, a randomized prospective study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Anyone who has had a serious allergic reaction to a prior dose of the hepatitis B vaccine, a component of the hepatitis B vaccine, or yeast should not receive the hepatitis B vaccine.
Those who had previous exposure to hepatitis B.
Post liver transplant patients.
Less than 18 years old.
Trial design
Design model
Parallel
Treatments tested in this trial
Heplisav-B Injectable Product, 2-dose regimen
Biological/VaccineInvestigators will randomly assign patients into a 2-dose regimen.
Heplisav-B Injectable Product, 3-dose regimen
Biological/VaccineInvestigators will randomly assign patients into a 3-dose regimen.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: Cirrhosis, 3-dose regimenExperimental treatment 1 intervention
Group B: Cirrhosis, 2-dose regimenActive comparator 1 intervention
Group C: Non cirrhosis, 3-dose regimenExperimental treatment 1 intervention
Group D: Non cirrhosis, 2-dose regimenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The rates of seroconversion after two doses of Heplisav-B given at 0 and 4 weeks versus three doses of Heplisav-B given at 0, 4 weeks, and 8 weeks.
The rates of seroconversion is defined as an HBsAg antibody concentration ≥ 10 mIU/ml.
Time frame
12 weeks after completing Heplisav-B series with two doses or three dosesSecondary outcomes
1
Factors are associated with a lower likelihood of achieving immunogenicity, such as age, race, MELD scores, etiologies of cirrhosis, comorbidity, immunosuppressive drugs. Those information will be measured or described descriptively by chart review.
Age (years) Race (White, Black, Other). MELD (Model For End-Stage Liver Disease) score: 6-40 Etiologies of cirrhosis will include: Nonalcoholic Fatty Liver Disease (Yes/No). Hepatitis C (Yes/No). Alcohol induced Liver Disease (Yes/No). Autoimmune Hepatitis (Yes/No). Primary Biliary Cholangitis (Yes/No). Primary Sclerosing Cholangitis (Yes/No). Comorbidity will include: Chronic obstructive pulmonary disease (Yes/No). Diabetes mellitus (Yes/No). Hypertension (Yes/No). Coronary artery disease (Yes/No). Acute renal injury (Yes/No). Chronic renal disease (Yes/No). Obesity (Yes/No). The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. A BMI of 30 and higher is considered obese. Immunosuppressive drugs (Yes/No).
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov